Cleared Traditional

K984183 - PERMA-PASS VASCULAR GRAFT

K984183 is the FDA 510(k) clearance for PERMA-PASS VASCULAR GRAFT by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYF) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K984183 · Possis Medical, Inc. · Cardiovascular device
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Feb 1999
Decision
70d
Days
Class 2
Risk

K984183 is an FDA 510(k) clearance for the PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 1999 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Possis Medical, Inc. devices

Submission Details

510(k) Number K984183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date February 01, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 9
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K984183.
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · W.L. Gore & Associates, Inc. · Sep 1999
DIASTAT VASCULAR ACCESS GRAFT
K955533 · W.L. Gore & Associates, Inc. · May 1996
DIASTAT VASCULAR ACCESS GRAFT
K953287 · W.L. Gore & Associates, Inc. · Oct 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · Baxter Healthcare Corp · Mar 1995
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · W.L. Gore & Associates, Inc. · May 1994
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · W.L. Gore & Associates, Inc. · Dec 1993